COLLAPSIBLE VALVE WITH INTERNAL DIMPLES

Description

[0001] The present invention generally relates to needleless connectors, and, in particular, to connectors with an internal collapsible valve.

Description of the Related Art

[0002] Medical treatments often include the infusion of a medical fluid, for example a saline solution or a liquid medication, to patients using an intravenous (IV) catheter that is connected though an arrangement of flexible tubing and fittings, commonly referred to as an "IV set," to a source of fluid, for example an IV bag. The fittings commonly include interconnectable male and female needleless connectors having a "Luer taper" conforming to an International Standards Organization (ISO) standard. Certain connectors have a self-sealing feature to prevent leakage of fluid from the attached tubing when the connector is decoupled from a mating connector.

[0003] One challenge with certain conventional needleless self-sealing connectors is that the medical fluid passing through the connector may become trapped in crevices and recesses within the connector. As certain types of medical fluids may degrade within a treatment time period, retention of medical fluid within the connector is undesirable.

[0004] US 5 555 908 A discloses medical access devices and more particularly a valved adapter useful with a variety of medical access devices. Further WO 2011/014265 discloses collapsable valves for use in medical devices.

SUMMARY

[0005] It is advantageous to provide a needleless connector that does not trap fluid within the connector during use. The disclosed female connector provides a smooth surface within the fluid path through the connector by positioning dimples that guide the collapse of the internal valve on a surface that is not wetted by the fluid.

[0006] The invention is defined by by claim 1 and further embodiments by the dependent claims. In the following, parts of the description and drawings referring to embodiments which are not covered by the claims are not presented as embodiments of the invention, but as examples useful for understanding the invention.

[0007] A needleless connector is disclosed that includes a body having an internal cavity with a sealing ridge, a port, an output flow channel, and a fluid flow path between the port and output flow channel. The connector also includes a collapsible valve disposed within the cavity. The valve comprises a cylindrical wall having a center axis, an internal surface, and a shoulder configured to sealingly contact the ridge of the body, thereby blocking the fluid flow path. The valve also comprises a head fixedly attached to the wall. The head has a smiley cut at a first angular position about the center axis and a continuous top surface that is generally perpendicular to the axis. The valve also comprises a first dimple formed in the internal surface of the cylindrical wall, the dimple extending around the internal surface over an angle in the range of 90-270°.

[0008] A collapsible valve is disclosed that includes a cylindrical wall having a center axis and an internal surface and a head fixedly attached to the wall. The head has a smiley cut at a first angular position about the center axis and a continuous top surface that is generally perpendicular to the axis. The valve also includes a first dimple formed in the internal surface of the cylindrical wall. The dimple extends around the internal surface over an angle in the range of 90-270°.

BRIEF DESCRIPTION OF THE DRAWINGS

[0009] The accompanying drawings together with the description serve to explain the principles of the disclosed embodiments. In the drawings:

FIGS. 1A-1B are cross-sections of a conventional connector illustrating how fluid may become trapped within the connector body.

FIGS. 2A-2C depict an exemplary collapsible valve according to the invention.

FIG. 3 is a cross-section of an example embodiment of an internal dimple.

FIGS. 4A-4B depict another embodiment of a collapsible valve.

FIGS. 5A-5B depict an example not forming part of the invention of a collapsible valve.

FIG. 6 is a cross-section of an exemplary needleless connector having a collapsible valve with internal dimples according to the invention.

DETAILED DESCRIPTION

[0010] It is advantageous to provide a needleless connector that does not trap fluid within the connector during use. The disclosed female connector provides a smooth surface within the fluid path through the connector by positioning dimples that guide the collapse of the internal valve on a surface that is not wetted by the fluid.

[0011] In the following detailed description, numerous specific details are set forth to provide a full understanding of the present disclosure. It will be apparent, however, to one ordinarily skilled in the art that embodiments of the present invention may be practiced without some of the specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the disclosure. In the referenced drawings, like numbered elements are the same or essentially similar. Reference numbers may have letter suffixes appended to indicate separate instances of a common element while being referred to generically by the same number without a suffix letter.

[0012] While the following discussion is directed to the administration of medical fluid to a patient by a nurse using an IV set having the disclosed connectors, this is only an example of usage and does not limit the scope of the claims. The disclosed connectors may be used in any application where it is desirable to avoid trapping fluid within a self-sealing connector.

[0013] FIGS. 1A-1B are cross-sections of a conventional connector 10 illustrating how fluid may become trapped within the connector body 50. With reference to FIG. 1A, the connector 10 includes a collapsible valve 20 disposed within a cavity 51 of body 50. The valve 20 has a shoulder 30 that continuously contacts a ridge 54 within the cavity 51 when the connector 10 is de-activated, i.e. not connected to a mating connector, to form a primary seal that blocks the fluid flow path through the connector 10. At the same time, a top surface 24 of the valve 20 is positioned generally flush with a port 52 of the cavity 51 and the edge of the continuous top surface 24 seals to the port 52. The top surface 24 is continuous, i.e. there is no slit or penetration in the surface that may trap bacteria or other contamination. The valve 20 has an internal air space 32 that is separated from the cavity 51 by a cylindrical wall 28. The air space 32 is vented to the ambient environment through air passages 56 and the external cavity 58 within the threaded connector 38 surrounding the male Luer fitting 39 of the body 50, as indicated by the air flow path 70. The valve 20 also has a solid head 22 with a "smiley cut" 26 formed on one side.

[0014] The valve 20 has a pair of external dimples 40 formed in the wall 28 that control the collapse of the valve 20 when an axial force is applied to the external surface 24. The two dimples 40 are typically on opposite sides of the wall 28 and axially offset from each other. The center of the dimples 40 are aligned in a common place with the center of the smiley cut 26.

[0015] FIG. 1B depicts the valve 10 in the activated position, i.e. a male Luer fitting 2 sealingly coupled to the connector 10 at port 52. The tip of the male Luer fitting 2 has displaced the external surface 24 downward and the applied force has caused the head 22 to buckle toward the smiley cut 26 as well as causing the cylindrical wall 28 to buckle in a plane that passes through the two external dimples 40. The primary seal between the shoulder 30 and ridge 54 is opened such that the fluid flow path through the connector 10 is open, as indicated by the fluid flow path 80 that passes from the lumen 3 of the male Luer fitting 2 through the cavity 51 and through channels 62 in the base and out through an output flow channel 64 of the male fitting 39 that is fluidly coupled to the flow channel 5 of the connected female Luer fitting 4. Air passes out of the air chamber 32 along the air flow path 70 as the valve 20 collapses.

[0016] It can be seen in FIG. 1B that the external dimples 40 have folded over and formed enclosed spaces that may trap a portion of the fluid passing through the cavity 51. Even if the enclosed spaces are not completely sealed, there may be very little if any circulation through the enclosed spaces and, therefore, fluid remains static within the enclosed spaces. As certain types of medical fluids may degrade within the time period that it takes to administer the medical fluid, retention of the medical fluid within the connector may allow the medical fluid to degrade before reaching the patient.

[0017] FIGS. 2A-2C depict an exemplary collapsible valve 100 according to certain aspects of the invention. FIG. 2A is an external view showing the head 22 with a smiley cut 26 and a cylindrical wall 104.

[0018] FIG. 2B is a cross-section of the valve 100 taken along the section line B-B shown in FIG. 2A. In this embodiment, there are three internal dimples 110, labeled as 110A, 110B, and 110C, formed in an internal surface 106 of the wall 104. In this example, dimples 110A and 110B are in close axial proximity to each other and angularly aligned with each other about a center axis 101. The dimple 110C is, in this example, axially offset from both of the dimples 110A, 110B and positioned 180° away from the dimples 110A, 110B about the axis 101. In certain embodiments, there may be only a single internal dimple 110. In certain embodiments, there may be two dimples 110. In certain embodiments, the two dimples 110 may be axially aligned with each other, i.e. with their centers on a common plane (not shown) that is perpendicular to the axis 101. In certain embodiments, the dimples 110 have a common depth that is approximately half the thickness of the wall 104. In certain embodiments, the dimples 110 may have different depths. In certain embodiments, one dimple 110 may be angularly offset about the axis 101 from another dimple 110.

[0019] FIG. 2C is a cross-section taken of a complete valve 100 at the location indicated by the section line C-C in FIG. 2B. It can be seen that the dimple 110C, in this example, has a variable depth over the circumferential length of the dimple 110C that extends over an angle 112. In this example, the depth is zero at the tips with a maximum at the center of the dimple 110c. In certain embodiments, the depth may be constant over the angle 112. In FIG. 2C, the angle is approximately 180°. In certain embodiments, the angle may be greater than or less than 180°.

[0020] FIG. 3 is a cross-section of an example embodiment of an internal dimple 130 formed in an inner surface 126 of a wall 124 wherein the external surface 128 of the wall 124 is deformed adjacent to the dimple 110 such that the dimple 130 has a depth that is greater than the thickness of the wall 124.

[0021] FIGS. 4A-4B depict another embodiment of a collapsible valve 200 according to the invention. FIG. 4A is a cross-section of the entire valve 200 showing that the collapsible valve 200 has two internal dimples 210A, 210B formed in wall 204 that are axially offset from each other and aligned with the smiley cut 26 on opposite sides of the center axis 201.

[0022] FIG. 4B is a cross-section taken of a complete valve 200 at the location indicated by the section line D-D in FIG. 4A. The dimple 210B has an angular span of angle 212 that is, in this example, approximately 90°.

[0023] FIGS. 5A-5B depict an example not forming part of the invention of a collapsible valve 300. FIG. 5A is a cross-section of the entire valve 300 showing that the collapsible valve 300 has internal dimple 310A with a second dimple 310B (not visible in FIG. 5A) formed on the opposite side of the wall 304. The dimples 310A, 310B are aligned with each other in a common plane that passes through the center axis 301 and is perpendicular to the location of the smiley cut 326 relative to the axis 301.

[0024] FIG. 5B is a cross-section taken of a complete valve 300 at the location indicated by the section line E-E in FIG. 5A. The dimple 310A has an angular span of angle 212 that is, in this example, approximately 100° and is formed at a location that is approximately 90° offset about the axis 301 from the angular position of the smiley cut 326.

[0025] FIG. 6 is a cross-section of an exemplary needleless connector 400 having a collapsible valve 405 with internal dimples 410 according to the invention. The body 450 is generally similar to the body 50 of the connector 10 of FIGS. 1A-1B. The valve 405 has two internal dimples 410A, 410B that are axially offset and arranged on opposite sides of the valve 405, similar to the valve 200 of FIGS. 4A-4B. Other features of the valve 405 are generally similar to the valve 20 of connector 10.

[0026] It can be seen that the disclosed embodiments of the needleless connector provide a fluid flow path that does not trap fluid within folded dimples on the external surface of a collapsible internal valve. Positioning the dimples within the internal air space separates the dimples from the fluid path while still providing control of the collapse of the disclosed valve.

[0027] The previous description is provided to enable any person skilled in the art to practice the various aspects described herein. While the foregoing has described what are considered to be the best mode and/or other examples.

[0028] Terms such as "top," "bottom," "front," "rear" and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.

[0029] The word "exemplary" is used herein to mean "serving as an example or illustration." Any aspect or design described herein as "exemplary" is not necessarily to be construed as preferred or advantageous over other aspects or designs.

Claims

1. A needleless connector (400) comprising:

a body (450) having a first port, a second port, and an internal cavity between the first and second ports; and

a collapsible valve (405) comprising a cylindrical wall (124) and a head (22) fixedly attached to the cylindrical wall (124), the head (22) having a smiley cut (26), the cylindrical wall (124) having a center axis (101), an internal surface (126) and an external surface (128) having a shoulder (30), the internal surface comprising a first dimple (130, 110A) and a second dimple (110B), the first dimple (130, 110A) extending along (i) a first plane transverse to the center axis (101) and (ii) a portion of a circumference of the internal surface, the second dimple extending along (i) a second plane, spaced apart from the first plane, and (ii) a portion of a circumference of the internal surface, the external surface comprising a deformation aligned with the first dimple (130, 110A) such that the first dimple (130, 110A) has a depth greater than the thickness of the cylindrical wall (124) when the valve (405) is in an unactivated position;

wherein in the unactivated position, the head (22) extends into the first port to form a primary seal, and in an activated position, the head (22) is within the internal cavity to open the primary seal.

2. The needleless connector (400) of Claim 1, wherein the second port is opposite the first port, and the shoulder is configured to sealingly contact an internal surface of the body (450) when the valve (405) is in the unactivated position, thereby blocking the first port.

3. The needleless connector (400) of Claim 1, wherein the first dimple (130, 110A) extends away from the center axis (101).

4. The needleless connector (400) of Claim 3, wherein the first plane is perpendicular to the center axis (101).

5. The needleless connector (400) of Claim 3, wherein the internal surface comprises a third dimple (110C) extending toward the center axis (101).

6. The needleless connector (400) of Claim 1, further comprising a third dimple (110C) formed on the internal surface, wherein the first dimple (130, 110A) extends around a first portion of the circumference through the first plane, and the third dimple (110C) extends around a second portion of the circumference through the first plane.

7. The needleless connector (400) of Claim 6, wherein the first portion of the circumference is angularly offset from the second portion of the circumference.

8. The needleless connector (400) of Claim 1, further comprising a third dimple (110C) formed on the internal surface, wherein the third dimple (110C) is axially offset from the first dimple (130, 110A).

9. The needleless connector (400) of Claim 1, further comprising a third dimple formed on the internal surface, wherein the third dimple is angularly offset from the first dimple (130, 110A).

10. The needleless connector (400) of Claim 1, wherein the first dimple (130, 110A) comprises a depth that varies along a length of the first dimple (130, 110A).

11. The needleless connector (400) of Claim 1, wherein the collapsible valve (405) comprises an internal air space (32) fluidly coupled to an air passage of the body (450).

12. The needleless connector (400) of Claim 1, wherein in the unactivated position, the valve (405) is unrestrained, and in an activated position, the valve (405) is compressed along the center axis (101).

13. The needleless connector (400) of Claim 11, wherein a fluid flow path is formed between an outer surface of the collapsible valve (405) and the body (450).

14. The needleless connector (400) of Claim 12, wherein the internal air space (32) is fluidly separated from the fluid flow path when the valve (405) is in the unactivated position and the activated position.

Ansprüche

1. Nadelloser Verbinder (400), aufweisend:

einen Korpus (450) mit einer ersten Öffnung, einer zweiten Öffnung und einem Innenhohlraum zwischen der ersten und zweiten Öffnung; und

ein zusammendrückbares Ventil (405) mit einer Zylinderwand (124) und einem Kopf (22), der fest an der Zylinderwand (124) angebracht ist, wobei der Kopf (22) einen sichelförmigen Einschnitt (26) hat, die Zylinderwand (124) eine Mittelachse (101), eine Innenfläche (126) und eine Außenfläche (128) mit einer Schulter (30) hat, die Innenfläche eine erste Vertiefung (130, 110A) und eine zweite Vertiefung (110B) hat, die erste Vertiefung (130, 110A) sich entlang (i) einer ersten Ebene quer zur Mittelachse (101) und (ii) eines Teils eines Umfangs der Innenfläche erstreckt, die zweite Vertiefung sich entlang (i) einer zweiten, von der ersten Ebene beabstandeten Ebene und (ii) eines Teils eines Umfangs der Innenfläche erstreckt, die Außenfläche eine mit der ersten Vertiefung (130, 110A) ausgerichtete Verformung aufweist, derart, dass die erste Vertiefung (130, 110A) eine Tiefe hat, die größer als die Dicke der Zylinderwand (124) ist, wenn das Ventil (405) in einer nicht aktivierten Position ist;

wobei sich in der nicht aktivierten Position der Kopf (22) in die erste Öffnung hinein erstreckt, um eine Primärdichtung zu bilden, und

in einer aktivierten Position der Kopf (22) sich im Innenhohlraum befindet, um die Primärdichtung zu öffnen.

2. Nadelloser Verbinder (400) nach Anspruch 1, wobei die zweite Öffnung entgegengesetzt zur ersten Öffnung ist und die Schulter dafür ausgelegt ist, abdichtend eine Innenfläche des Korpus (450) zu berühren, wenn das Ventil (405) in der nicht aktivierten Position ist, wodurch die erste Öffnung blockiert wird.

3. Nadelloser Verbinder (400) nach Anspruch 1, wobei sich die erste Vertiefung (130, 110A) von der Mittelachse (101) weg erstreckt.

4. Nadelloser Verbinder (400) nach Anspruch 3, wobei die erste Ebene senkrecht zur Mittelachse (101) ist.

5. Nadelloser Verbinder (400) nach Anspruch 3, wobei die Innenfläche eine dritte Vertiefung (110C) aufweist, die sich zur Mittelachse (101) hin erstreckt.

6. Nadelloser Verbinder (400) nach Anspruch 1, darüber hinaus mit einer dritten Vertiefung (110C), die an der Innenfläche gebildet ist, wobei sich die erste Vertiefung (130, 110A) um einen ersten Teil des Umfangs durch die erste Ebene erstreckt und sich die dritte Vertiefung (110C) um einen zweiten Teil des Umfangs durch die erste Ebene erstreckt.

7. Nadelloser Verbinder (400) nach Anspruch 6, wobei der erste Teil des Umfangs gegenüber dem zweiten Teil des Umfangs winkelmäßig versetzt ist.

8. Nadelloser Verbinder (400) nach Anspruch 1, darüber hinaus mit einer dritten Vertiefung (110C), die an der Innenfläche gebildet ist, wobei die dritte Vertiefung (110C) gegenüber der ersten Vertiefung (130, 110A) axial versetzt ist.

9. Nadelloser Verbinder (400) nach Anspruch 1, darüber hinaus mit einer dritten Vertiefung, die an der Innenfläche gebildet ist, wobei die dritte Vertiefung gegenüber der ersten Vertiefung (130, 110A) winkelmäßig versetzt ist.

10. Nadelloser Verbinder (400) nach Anspruch 1, wobei die erste Vertiefung (130, 110A) eine Tiefe aufweist, die sich entlang einer Länge der ersten Vertiefung (130, 110A) ändert.

11. Nadelloser Verbinder (400) nach Anspruch 1, wobei das zusammendrückbare Ventil (405) einen internen Luftraum (32) aufweist, der fluidisch mit einem Luftdurchlass des Korpus (450) gekoppelt ist.

12. Nadelloser Verbinder (400) nach Anspruch 1, wobei in der nicht aktivierten Position das Ventil (405) nicht eingeschränkt wird und in einer aktivierten Position das Ventil (405) entlang der Mittelachse (101) zusammengedrückt ist.

13. Nadelloser Verbinder (400) nach Anspruch 11, wobei zwischen einer Außenfläche des zusammendrückbaren Ventils (405) und dem Korpus (450) ein Fluidströmungspfad gebildet ist.

14. Nadelloser Verbinder (400) nach Anspruch 12, wobei der interne Luftraum (32) fluidisch vom Fluidströmungspfad getrennt ist, wenn das Ventil (405) in der nicht aktivierten Position und der aktivierten Position ist.

Revendications

1. Connecteur sans aiguille (400) comprenant :

un corps (450) présentant un premier raccord, un deuxième raccord, et une cavité interne entre le premier et le deuxième raccord ; et

une valve (405) repliable comprenant une paroi cylindrique (124) et une tête (22) attachée fixement à la paroi cylindrique (124), la tête (22) présentant une découpe en frimousse (26), la paroi cylindrique (124) ayant un axe médian (101), une surface interne (126) et une surface externe (128) présentant un épaulement (30), la surface interne comprenant une première fossette (130, 110A) et une deuxième fossette (110B), la première fossette (130, 110A) s'étendant le long (i) d'un premier plan transversal à l'axe médian (101) et (ii) d'une partie d'une circonférence de la surface interne, la deuxième fossette s'étendant le long (i) d'un deuxième plan, espacé du premier plan, et (ii) d'une partie d'une circonférence de la surface interne, la surface externe comprenant une déformation alignée avec la première fossette (130, 110A) de telle sorte que la première fossette (130, 110A) ait une profondeur supérieure à l'épaisseur de la paroi cylindrique (124) lorsque la valve (405) est dans une position inactivée ;

sachant que dans la position inactivée, la tête (22) s'étend dans le premier raccord pour former un joint d'étanchéité primaire, et dans une position activée, la tête (22) se trouve dans la cavité interne pour ouvrir le joint d'étanchéité primaire.

2. Le connecteur sans aiguille (400) de la revendication 1, sachant que le deuxième raccord est opposé au premier raccord, et l'épaulement est configuré pour être en contact étanche avec une surface interne du corps (450) lorsque la valve (405) est dans la position inactivée, bloquant de la sorte le premier raccord.

3. Le connecteur sans aiguille (400) de la revendication 1, sachant que la première fossette (130, 110A) s'étend en éloignement de l'axe médian (101).

4. Le connecteur sans aiguille (400) de la revendication 3, sachant que le premier plan est perpendiculaire à l'axe médian (101).

5. Le connecteur sans aiguille (400) de la revendication 3, sachant que la surface interne comprend une troisième fossette (110C) s'étendant vers l'axe médian (101).

6. Le connecteur sans aiguille (400) de la revendication 1, comprenant en outre une troisième fossette (110C) formée sur la surface interne, sachant que la première fossette (130, 110A) s'étend autour d'une première partie de la circonférence à travers le premier plan, et la troisième fossette (110C) s'étend autour d'une deuxième partie de la circonférence à travers le premier plan.

7. Le connecteur sans aiguille (400) de la revendication 6, sachant que la première partie de la circonférence est décalée angulairement par rapport à la deuxième partie de la circonférence.

8. Le connecteur sans aiguille (400) de la revendication 1, comprenant en outre une troisième fossette (110C) formée sur la surface interne, sachant que la troisième fossette (110C) est décalée axialement par rapport à la première fossette (130, 110A).

9. Le connecteur sans aiguille (400) de la revendication 1, comprenant en outre une troisième fossette formée sur la surface interne, sachant que la troisième fossette est décalée angulairement par rapport à la première fossette (130, 110A).

10. Le connecteur sans aiguille (400) de la revendication 1, sachant que la première fossette (130, 110A) comprend une profondeur qui varie le long d'une longueur de la première fossette (130, 110A).

11. Le connecteur sans aiguille (400) de la revendication 1, sachant que la valve (405) repliable comprend un espace d'air interne (32) couplé fluidiquement à un passage d'air du corps (450) .

12. Le connecteur sans aiguille (400) de la revendication 1, sachant que dans la position inactivée, la valve (405) est non restreinte, et dans une position activée, la valve (405) est comprimée le long de l'axe médian (101).

13. Le connecteur sans aiguille (400) de la revendication 11, sachant qu'un chemin d'écoulement de fluide est formé entre une surface extérieure de la valve (405) repliable et le corps (450).

14. Le connecteur sans aiguille (400) de la revendication 12, sachant que l'espace d'air interne (32) est séparé fluidiquement du chemin d'écoulement de fluide lorsque la valve (405) est dans la position inactivée et la position activée.

Drawing